{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Non-Inferiority Clinical Trials to Establish Effectiveness.\" This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/11/08/2016-26931.html","cfr_references":[],"citation":"81 FR 78605","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0075"],"dockets":[],"document_number":"2016-26931","effective_on":null,"end_page":78606,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/08/2016-26931.xml","html_url":"https://www.federalregister.gov/documents/2016/11/08/2016-26931/non-inferiority-clinical-trials-to-establish-effectiveness-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-26931?publication_date=2016-11-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-08/2016-26931/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1607,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-08/pdf/2016-26931.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-26931.pdf?1478526352","publication_date":"2016-11-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/08/2016-26931.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0075","supporting_documents_count":0,"docket_id":"FDA-2010-D-0075","regulation_id_number":null,"title":"Non-Inferiority Clinical Trials","checked_regulationsdotgov_at":"2016-11-28T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78605,"subtype":null,"title":"Non-Inferiority Clinical Trials To Establish Effectiveness; Guidance for Industry; Availability","toc_doc":"Non-Inferiority Clinical Trials to Establish Effectiveness","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}